After getting the green light from the FDA back in March, Dexcom today launched its first over-the-counter wearable continuous glucose biosensor, Stelo, in the U.S. market.
The device is now available for purchase without a prescription at Stelo.com. Dexcom designed Stelo for adults 18 years and older who are not taking any insulin therapies—a group that includes about 25 million people living with Type 2 diabetes in the U.S. It's also designed to help those with prediabetes reach their A1c goals and potentially slow the progression of diabetes, according to the company. Also, people without diabetes can use the device to better understand the effects of diet and exercise, the company said.
Unveiled earlier this year, Dexcom has pitched the Stelo as a more “health-focused” version of its top-of-the-line CGM, the G7, which made its debut early last year. Though built on the same sensor platform, the Stelo will operate without the low blood sugar alerts or software features needed by people with Type 1 diabetes, who use real-time glucose data to carefully calculate their daily doses of insulin.
The FDA cleared Dexcom's Stelo in March. Abbott followed in June, collecting FDA clearances for two separate continuous glucose monitoring systems, the Libre Rio and the Lingo. While the Libre Rio is designed for adults with Type 2 diabetes who are not taking insulin, the Lingo carries a more general “health and wellness” focus, aimed at providing blood sugar data to the curious consumer.
Worn on the back of the upper arm, the sensor can deliver 24/7 glucose readings to a smartphone app for up to 15 days. It's designed to provide personalized glucose insights revealing how food, exercise and sleep can affect glucose, and does not use fingersticks.
Launching an over-the-counter glucose biosensing device expands access to continuous glucose monitoring technology, Jake Leach, executive vice president and chief operating officer at Dexcom, said during a Dexcom event in Manhattan last week introducing the device to journalists.
"Right now, before Stelo, there's been a lot of great access to CGM through a prescription and insurance reimbursement for people with diabetes who use insulin, and it's only about a third of the people in the U.S. that have diabetes, and it obviously doesn't cover any of the prediabetes. We've seen lots of data that shows the outcomes you can create using this technology in this broad group of people. It was about making it more accessible. The over-the-counter component and the price point were designed specifically to allow more people to benefit," he told Fierce Healthcare, covering the news for Fierce Biotech.
Stelo is a cash-pay product and costs $99 for a single pack of two sensors, with total wear time up to 30 days. Consumers also can pay for a monthly subscription at $89 per month, with two sensors delivered every 30 days.
The company says it's the longest biosensor wear time on the market with the highest waterproof rating. The device provides daily, weekly and session summary insights via the app. The glucose biosensor also features spike detection to identify meaningful glucose variability as it happens so users can make informed changes.
“Dexcom glucose biosensors are an essential and proven tool for diabetes management—driving strong clinical outcomes regardless of medication use9 and even potentially slowing the progression of diabetes,” said Thomas Grace, M.D., head of clinical advocacy and outcomes at Dexcom, in a statement. “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective."
The device combined with the app is designed to deliver 24/7, easy-to-understand glucose insights that can inform consumers' daily lifestyle choices and support behavior modification, company executives said.
"A big part of the product that we designed was the educational component because we understand that most people who are going to try this product have never seen their glucose data, particularly not continuously, but most probably haven't even pricked their finger before," Leach said. "There's the whole education around how glucose changes all throughout the day. It changes quite differently based on what you eat. The idea is to use the information from the glucose biosensor to change your habit of what you're eating. CGM, in essence, is quite an education tool, because it gives you access to information you've never seen before."
Along with personalized glucose insights, the app also delivers educational content about glucose and nutrition.
Dexcom sees a massive market opportunity for over-the-counter, cash-pay glucose biosensing devices.
"I think because it's over the counter and the availability, we're going to get a lot of different types of users. Our main focus was that group that has diabetes, not on insulin or pre diabetes, and that's 125 million people," Leach said. "Right now, the use of CGM is very concentrated into that 12 to 13 million that are on insulin in the U.S., and even there, it's less than half penetrated. But this other group it's about single digit percentage penetration. There's a ton of opportunity for people to benefit. That's where we see the biggest opportunity."
He added, "I think, over time, we're going to learn more about glucose dynamics and how it impacts longevity in people dealing with diabetes. I mean, my dream is that this technology helps us curb diabetes and obesity rates in the U.S. I think it's part of the picture, along with all the other advances that are going on. I think this is a tool that can really help people learn more about what's going on that you just can't do without it."